This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).
This Small Business Innovation Research Phase II project will continue development of the Tube-Clear(TM) device to clear clogged and sluggish feeding tubes, satisfying a critical medical need and reaching a viable commercial market. When compromised patients are unable to swallow food or medication, feeding tubes are used to administer medication and nutrition. A clog leaves the patient without medication or nutrition for hours, or even days, and is extremely frustrating to both patient and caregiver. Approximately 410,000 PEG (long-term) tubes and 5 million NG (short-term) tubes are placed each year in the U.S. Each type of tube presents specific challenges for feeding, clogging and cleaning. The Tube-Clear(TM) PEG prototype cleaned a clog of food and ground medication, in less than one minute, that could not be easily removed using any other available approach. Demonstration of the PEG alpha-prototype at four focus groups, for over 20 nurses from a variety of clinical settings, produced an overwhelmingly positive response toward the device. Phase II (following on Phase IB) will further develop both the PEG tube and NG tube cleaners to beta-prototypes, take the devices through clinical trials, and establish manufacturing protocols, all under a Food and Drug Administration compliant quality system.
The Tube-Clear will ease the burden on nursing staff and patients dealing with the frustration of clogged and sluggish feeding tubes. A structured financial and technical plan has been put in place using a combination of funds from SBIR (Phase I, IB, II and IIB), the State of Pennsylvania, Commercial Partners, and equity investment to reach specific milestones over a 2.5 year period. The NSF Phase I project kicked off this development effort with a highly successfully Alpha prototype for PEG tubes, which was tested in a series of nursing focus groups, resulting in extremely positive reviews. The Tube-Clear for PEG cleaning has an anticipated market launch date in 2010, followed by a NG tube cleaning device market launch in 2011. By 2013, Piezo Resonance Innovations (PRII) anticipates revenue for the Tube-Clear (TM) of $25-50 Million. Three commercial partners, with presence in the enteral feeding market, have indicated strong interest in the device and would provide access to their paths to market, marketing staff, and device development expertise. They have also expressed willingness to contribute financially, potentially as Phase IIB partners. PRII staff will also teach guest lectures on medical device design in the Penn State School of Nursing.
This National Science Foundation (NSF) SBIR program developed TubeClear®, an activated device for reliable clearing of blocked and sluggish feeding tubes. Feeding tubes are used to provide essential nutrition and medications to patients who cannot eat normally. Patients may receive a feeding tube for a number of reasons including traumatic injury, Alzheimer’s disease, cancer, GI-tract malfunction or disease. Unfortunately these small lumens are prone to clogging. Clogging creates hassle and frustration for patient and clinician alike, as well as delays in feeding and medication. Clogged feeding tubes often result in a trip to the ER, a replacement tube, and potentially even a surgical procedure. TubeClear uses a single-use Clearing Stem that is connected to a reusable Control Box and is then inserted into the clogged tube. The Control Box applies a gentle mechanical motion to the Clearing Stem which acts to break up the clog. More detailed information on how TubeClear works is available at the website (www.tubeclear.com). To gain market awareness and sales, AMI exhibited TubeClear at the Nursing Training Institute National Conferences in 2013 and 2014 and at ASPEN 2012, 2013, and 2014. The exhibitions resulted in a constant crowd at the AMI booth to demo TubeClear and ~2000 solid leads for future sales. This enthusiasm was also a major advantage in attracting the interest of a company to license sales, marketing and distribution. CORPAK MedSystems, a major player in the international enteral/vascular access device market, signed a distribution agreement for TubeClear technology in March 2014. Regulatory clearances have been obtained in both the United States (FDA 510k), the EU (CE mark), and Canada (Medical Device License). TubeClear has been successfully used in about 25 patients, with the number rapidly growing. In these uses, TubeClear worked well and restored tube patency quickly. "Slick as a whistle," was a comment from one of the nurses using the device. In each of the uses, patients reported no pain and were returned to their feeding and/or medication regimens without the delay, risk, discomfort or cost of tube replacement. AMI possesses four U.S. Patents related to clearing occlusions in artificial tubes: U.S. Pat. 8,262,645, U.S. Pat. 8,574,377, U.S. Pat. 8,603,254, and U.S. Pat. 8,690,861. Related applications, including PCT and CIP applications, are pending. Additionally, AMI filed applications focusing on improvements for endotracheal applications: U.S. utility application, 14/052,278, "Active System for In-Situ Clearing of Secretions and Occlusions in Tubes," filed 10/2013; and PCT application, PCT/US13/64642, "Active System for In-Situ Clearing of Secretions and Occlusions in Tubes", filed 10/2013. As AMI refines devices and new opportunities for inventions are discovered, additional applications are filed to disclose and claim additional subject matter. Additional funding has been acquired to pursue additional indications for pediatrics and to apply the technology to other types of tubes placed in the body. A related project is underway to use the basic technology platform for gentler suctioning of endotracheal tubes in neonatal and pediatric patients, to reduce the burden on their lungs.
